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FDA 510(k)

PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE

K-Number: K901332 · 1990-05-09

ApplicantBiotronik, GmbH & Co.
Decision Date1990-05-09
Product CodeDTC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, GmbH & Co.. It received FDA 510(k) clearance on 1990-05-09 under 510(k) number K901332. The device is classified under product code DTC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE?

PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE is a medical device that received FDA 510(k) clearance on 1990-05-09. The listed applicant is Biotronik, GmbH & Co.. The 510(k) number is K901332.

When did PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE receive FDA 510(k) clearance?

PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE received FDA 510(k) clearance on 1990-05-09, under 510(k) number K901332.

Who is the listed applicant for PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE?

The FDA 510(k) record lists Biotronik, GmbH & Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE?

The FDA product code for PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE is DTC.

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Other records listing Biotronik, GmbH & Co. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K000763PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051K923406BIOSCOPEK923026PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKERK922742HPM 40 HEART PACEMAKER MONITORK914109PIKOS 01 & PIKOS E 01K910609PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP

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Related Devices (Code: DTC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K170815PSA CableBoston Scientific CorporationK083674PK-141 PATIENT CABLEBiotronik, Inc.K011729SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000Dni Nevada, Inc.K002497MODEL 4810 ANALYZER OUTPUT ADAPTERPace MedicalK961582EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100North American Technical Services Corp.K903966EXTERNAL PACEMAKER ANALYZER MODEL PMA-1Bio-Tek Instruments, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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